15 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

HUAYI H035 BASIC WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014604589·TABLE WIDTH EXTENDER PAD 15 X 8 X 1 DELUX

Conformis Hip System

FDA UDI
Conformis, Inc.·00850268007873·ITOTAL HIP INSTRUMENT CASE, AUXILIARY

LEONE SPA

FDA UDI
LEONE SPA·08033707000969·MICRO SECT SCREWS U S/STEEL 4mm EXPANS.

Slimplicity Anterior Cervical Plate System

FDA UDI
PRECISION SPINE, INC.·00815362021095·1 Level 14mm Plate

Symmetry Malis®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140055·Symmetry® Bipolar Forceps; Straight; Titanium; ...

ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)

FDA 510(k)
FDA Class 2 ·Ophthalmic

RS-4M+MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

CUSTOM CONVENIENCE KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code BYX·June 29, 2005

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2011

MEDFUSION 2001 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL MD·Product code FRN·July 17, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015